CytoDyn Inc., a late stage biotechnology company, is developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications and announced that the U.S. FDA has granted Fast Track Designation to leronlimab (PRO140) for use in combination with carboplatin for the treatment of patients with CCR5-positive metastatic triple-negative breast cancer (mTNBC).  Injection of the first patient in mTNBC is anticipated to be imminent.  Clinical trial sites include Quest Clinical Research in San Francisco, along with four additional trial sites, which are in the process of initiating patient enrollment, including: Northwestern University Medical School, Methodist Houston, Vanderbilt University and Sidney Kimmel Cancer Center.
 
“This is an important acknowledgement of the potentially paradigm-shifting therapy option in metastatic triple-negative breast cancer,” stated Dr. Richard Pestell, M.D., Ph.D, Vice Chairman and Chief Medical Officer of CytoDyn. “Currently, there are no enduring treatment options for mTNBC patients and, we thank the FDA for recognizing the potential of leronlimab for mTNBC patients,” continued Dr. Pestell. 
“We remain highly encouraged by the potential of leronlimab (PRO 140) as a pipeline of opportunities within a single drug franchise,” stated Dr. Nader Pourhassan, Ph.D, President, CEO and director.

Leronlimab (PRO 140) is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that appears to play multiple roles with implications in HIV infection, tumor metastases and immune signaling. Leronlimab (PRO 140) has successfully completed nine Phase 1/2/3 clinical trials in over 700 people, including a successful pivotal Phase 3 trial in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients.

In the setting of cancer, research has shown that CCR5 likely plays a central role in tumor invasion and metastasis and that increased CCR5 expression is an indicator of disease status in several cancers. Moreover, research has shown that drugs that block CCR5 can block tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. CytoDyn is conducting additional research with leronlimab (PRO 140) in the cancer setting and plans to initiate additional Phase 2 human clinical trials, in addition to triple-negative breast cancer, when appropriate.